SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS— 510(k) K033372

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K033372 for SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS, Substantially Equivalent on 2004-01-09. Applicant: Micro Therapeutics, Inc..

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2003-10-22
Decision date: 2004-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.